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Discussion
Feasibility
The acceptability for participation on the part of the patients can be considered
as low because only one patient out of 11 eligible patients gave informed consent
(Fig. 1). However, the decision for not participating is multifactorial and could probably
not be summarized in a single reason. It is hardly possible to judge whether the given
reason, the complex overall situation, the study design, the intervention, other reasons
or a combination of these factors have led to the patients’ decision. The low number
of eligible patients can be traced back to our eligibility criteria, which apparently
was not appropriate, and the low acceptability may be a consequence of different recruitment
barriers (see paragraphs below).
No patient completed the study. Therefore, no judgement can be made on the efficacy
of the intervention for this population (expansion) [16]......
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